Meniscus regeneration device

Abstract

Methods and devices are provided for regenerating a meniscus. The devices comprise a layer of toughened naturally occurring extracellular matrix. The devices may, optionally, further comprise a biologic material to provide a framework for meniscus regeneration. The methods comprise the steps of removing a portion of a meniscus to provide a space, and inserting a device comprising a layer of toughened naturally occurring extracellular matrix into the space.

1. A device for insertion into a space in a knee meniscus from which space a meniscus portion has been removed, the device comprising:
 a shell defining an interior space, said shell comprising an extracellular matrix selected from the group consisting of small intestine submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane that has been dehydrated by dehydrothermal cross-linking, wherein at least a portion of the dehydrothermal cross-linked extracellular matrix has a density of at least 0.9 gm/cm 3 . 
 
     
     
       2. The device of  claim 1  wherein a biological material is contained within the interior space of said shell. 
     
     
       3. An implantable device for regenerating at least a portion of a meniscus of a knee, the device comprising:
 a dehydrated cover sheet and 
 a mass of extracellular matrix selected from the group consisting of small intestine submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane, the dehydrated cover sheet extending over and beyond the mass of extracellular matrix, wherein at least a portion of the dehydrated cover sheet has a density of at least 0.9 gm/cm 3 . 
 
     
     
       4. The implantable device of  claim 3  wherein the extracellular matrix comprises small intestine submucosa. 
     
     
       5. The implantable device of  claim 4  wherein the small intestine submucosa comprises at least one material selected from the group consisting of: comminuted small intestine submucosa, small intestine submucosa pieces, small intestine submucosa foam, an small intestine submucosa roll, woven small intestine submucosa, non-woven small intestine submucosa mat, braided small intestine submucosa, small intestine submucosa solution, small intestine submucosa dispersion, small intestine submucosa slurry, small intestine submucosa gel, small intestine submucosa paste, and small intestine submucosa that has not been toughened. 
     
     
       6. The implantable device of  claim 3  wherein the cover sheet comprises at least one of the following: a biocompatible polymer and extracellular matrix selected from the group consisting of small intestine submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane. 
     
     
       7. The implantable device of  claim 3  further comprising at least one of the following: a bioactive agent, a biologically-derived agent, cells, a biological lubricant, a biocompatible polymer, and a biocompatible inorganic material. 
     
     
       8. The implantable device of  claim 3  further comprising at least one biologically compatible material associated with the mass of extracellular matrix, said biologically compatible material selected from the group consisting of: a bioactive agent, a biologically-derived agent, cells, a biological lubricant, a biocompatible polymer, and a biocompatible inorganic material. 
     
     
       9. The implantable device of  claim 3  wherein the cover sheet comprises a wedge-shaped body having an upper panel and a lower panel angularly separated to define an apex portion and a base portion. 
     
     
       10. The implantable device of  claim 9  wherein the mass of extracellular matrix is positioned between the upper panel and lower panel. 
     
     
       11. The implantable device of  claim 3  wherein the cover sheet has a toughness sufficient to at least temporarily withstand the forces of articulation at the knee without degrading. 
     
     
       12. The implantable device of  claim 3  wherein the cover sheet is treated to increase its density. 
     
     
       13. The implantable device of  claim 3  wherein the cover sheet has a density greater than the density of the mass of extracellular matrix. 
     
     
       14. An implantable device for regenerating at least a portion of a meniscus of a knee, the device comprising at least two adjacent dehydrated materials having different densities, wherein each of the materials comprises extracellular matrix selected from the group consisting of small intestine submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane, wherein at least a portion of one of the dehydrated materials is treated to increase its density to a density of at least 0.9 gm/cm 3 . 
     
     
       15. The implantable device of  claim 14  wherein the extracellular matrix comprises small intestine submucosa. 
     
     
       16. The implantable device of  claim 14  wherein one of the materials comprises a mass of biological material and the other material comprises a cover. 
     
     
       17. The implantable device of  claim 14  wherein at least a portion of the other dehydrated materials has a density greater than 0.5 gm/cm 3  when dehydrated. 
     
     
       18. An implantable device for repairing or regenerating at least a portion of the tissue of a vertebrate, the device comprising a sheet of extracellular matrix selected from the group consisting of small intestine submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane dehydrated to have a density of at least 0.9 gm/cm3, wherein the extracellular matrix has been dehydrated by dehydrothermal cross-linking. 
     
     
       19. The device of  claim 18  wherein the dehydrothermal cross-linking comprises applying mechanical pressure to the extracellular matrix while using vacuum to remove water. 
     
     
       20. The device of  claim 1  wherein the shell is formed as a wedge-shaped body having an upper panel and a lower panel angularly separated to define an apex portion and a base portion. 
     
     
       21. The device of  claim 20  wherein the upper and lower panels have outer edges joined together by dehydrothermal cross-linking, said joined edges having a density of at least 0.9 gm/cm 3 . 
     
     
       22. The device of  claim 21  wherein a biological material is contained within the interior space. 
     
     
       23. The device of  claim 22  wherein the biological material comprises fibrin, blood clot, platelet rich plasma, comminuted extracellular matrix or combinations thereof. 
     
     
       24. The device of  claim 22  wherein the biological material comprises material selected from the group consisting of comminuted small intestine submucosa, small intestine submucosa pieces, small intestine submucosa foam, an small intestine submucosa roll, woven small intestine submucosa, non-woven small intestine submucosa mat, braided small intestine submucosa, small intestine submucosa solution, small intestine submucosa dispersion, small intestine submucosa slurry, small intestine submucosa gel, small intestine submucosa paste, and small intestine submucosa that has not been toughened. 
     
     
       25. The implantable device of  claim 3  wherein the cover sheet comprises a biocompatible polymer and extracellular matrix selected from the group consisting of small intestine submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane.